Biomarkers and their Relationship to Tau and Amyloid PET Imaging in AD
Research type
Research Study
Full title
Development of a Database to Investigate Digital and Blood-Based Biomarkers and their Relationship to Tau and Amyloid PET Imaging in Older Participants Who are Cognitively Normal (CN), have Mild Cognitive Impairment (MCI), or have Mild-to-Moderate AD Dementia
IRAS ID
347438
Contact name
Josephine Macsweeney
Contact email
Sponsor organisation
GAP Innovations, PBC
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 0 days
Research summary
Alzheimer’s disease (AD) is characterised by the accumulation of amyloid-beta and tau protein deposits in the brain that disrupt healthy brain activity. Biomarkers can be used to detect AD and track disease changes. Biomarkers can be measured through blood or cerebrospinal fluid (CSF) testing, digitally through a variety of cognitive assessments or functional tasks or with brain imaging such as magnetic resonance imaging (MRI) and positron emission tomography (PET) scans. Further research is required to develop efficient, less invasive, and less costly tools and tests to identify participants who meet the requirements for AD research.
GAP Innovations, PBC is sponsoring a study to develop a blood, CSF, digital, MRI and PET brain scan biomarker database that can be used to determine the extent to which blood and CSF based and digital biomarkers, on their own, and in combination, predict the extent of amyloid in plaques and tau in tangles in the brain as measured by MRI and PET brain scans. Blood collected will also be genetically analysed to gain insights about genes and brain amyloid. From this database the development of a combination test could be an effective tool to identify patients who best meet the requirements for AD research.
The study will include approximately 1,200 participants between the ages of 60 - 90 years-old who are cognitively normal, have mild cognitive impairment, or have mild-to-moderate Alzheimer’s disease.
Patient participation in the core study will last up to 120 days and will involve 3 site visits. There is an optional sub-study at visit 3 which will involve collecting cerebral spinal fluid (CSF) via a lumbar puncture. After completion of the core study, an optional longitudinal sub-study enrolling approximately 300 participants from all three cohorts which will measure change in tau and other biomarkers over 12 months and 24 months.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0031
Date of REC Opinion
24 Mar 2025
REC opinion
Further Information Favourable Opinion